Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032580422

FEI Number

3032580422

Entity Name

YUAIKASEI CO.,LTD.

City/State/Country

Amagasaki Hyogo, JP

Establishment Address

6-1-35 Tano, Amagasaki Hyogo 6610951, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

YUAIKASEI CO.,LTD. (Owner Number: 10091375)

Owner / Operator Contact Address

6-1-35 Tano, Amagasaki, JP-28 6610951, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Concentrated Washing Solution 3 AUTION EYE Sheath Solution

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2024-09-10

Official Correspondent

SHIBASAKI MIDORI

US Agent Details

Yosuke Yamamoto Business: ARKRAY Factory USA, Inc. Email: yamamotoy@arkrayusa.com Phone: (612) 9461481

Related Public Records

Same Entity

YUAIKASEI CO.,LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032580422. Last updated year: 2026. Please use registration number 3032580422 when referencing this establishment in official correspondence.